First and Only Ablation Catheter Approved for Treatment of Heart Rhythm Disorder That Affects Up to 5 Million People in the U.S.
Biosense Webster, Inc., a Johnson & Johnson company, today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval to the NAVISTAR® THERMOCOOL® Catheter for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. Atrial fibrillation, or AFib, is a highly prevalent heart rhythm disorder and one of the most common causes of stroke. On November 20, 2008, the FDA’s Circulatory System Devices Panel unanimously recommended approval of the NAVISTAR® THERMOCOOL® Catheter for AFib. The NAVISTAR® THERMOCOOL® Catheter is the first and only ablation catheter in the U.S. to be approved for the treatment of this disorder, which affects an estimated 10 million people worldwide.
“Today’s announcement is a milestone for electrophysiologists, physicians who specialize in heart rhythm disorders, and their patients throughout the U.S.,” said Marcia S. Yaross, Ph.D., Vice President, Clinical, Regulatory and Health Policy, Biosense Webster. “This landmark decision by the FDA recognizes the safety and effectiveness of NAVISTAR® THERMOCOOL® Catheter ablation for the treatment of paroxysmal AFib and gives the medical community another treatment option for many patients whose often debilitating symptoms are not effectively managed through medical therapy.”
Conditions of approval include a post-marketing registry and a physician education program about use of the product.
The NAVISTAR® THERMOCOOL® Catheter is also approved in the U.S. for the treatment of Type 1 atrial flutter, and recurrent drug/device refractory sustained monomorphic ventricular tachycardia due to prior myocardial infarction (heart attack). Atrial flutter and ventricular tachycardia are two types of cardiac arrhythmia.
“Since it was founded, Biosense Webster has been a leading provider of innovative products for the treatment of heart rhythm disorders and continues to partner with electrophysiologists to help advance ablation options for the millions of patients with these conditions,” said Shlomi Nachman, Worldwide President, Biosense Webster. “Today’s approval continues our legacy of innovation.”
Today’s approval by the FDA also includes the EZ STEER® THERMOCOOL® Navigational Catheter, which is a bi-directional version of the catheter. These catheters are compatible with 3-D mapping systems which recognize the CARTO® System magnetic location sensors. These include the CARTO®, CARTO® XP, and CARTO® 3 EP Navigation Systems.